FDAClass IIIMay 17, 2017

PrednisoLONE Oral Solution USP recall

PrednisoLONE Oral Solution USP, 15 mg/5mL, alcohol content: 5%(v/v) 240 mL bottle, Rx Only, Manufactured in Canada By: CONTRACT PHARMACEUTICALS…

Why was PrednisoLONE Oral Solution USP recalled?

Failed Stability Specifications

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Lot # 94358; Exp. 05/17 Lot # 94920A; Exp. 07/17 Lot # 97083A; Exp. 12/17

Product
PrednisoLONE Oral Solution USP, 15 mg/5mL, alcohol content: 5%(v/v) 240 mL bottle, Rx Only, Manufactured in Canada By: CONTRACT PHARMACEUTICALS…
Recalling firm
Teva Pharmaceuticals USA
Quantity
49,089 bottles
Distribution
Nationwide
Recall date
May 17, 2017
Classification
Class III
Status
Terminated
Agency
FDA (drug)
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